By: Omar AL-Rawajfah, RN, PhD

The Need for Ethical Guidelines

Historical Background 1940s Nazi medical experiments

medical tortureMedical torture 1972 Tuskegee Syphilis study primed Willowbrook (1950s): Mentally retarded

children were deliberately injected with hepatitis virus to study its effects.

Jewish Chronic Disease Hospital (1960s) Live cancer cells were injected into 22 senile patients.

Injecting radioactive substances into babies and pregnant women

Feeding radioactive material to mentally disabled children

Documentary Texts In the Name of Science: A

History of Secret Programs, Medical Research, and Human Experimentation

Doctors from Hell: The Horrific Account of Nazi Experiments on Humans

Medical Apartheid: The Dark History of Medical Experimentation on Black Americans from Colonial Times to the Present

Code of Ethics: Nuremberg Code

The voluntary consent of the human subject is absolutely essential.

The experiment should be such as to yield fruitful results for the

good of society. The experiment should be so designed and based on the results

of animal experimentation that the anticipated results will justify the performance of the experiment.

The experiment should be so conducted as to avoid all

unnecessary physical and mental suffering and injury. No experiment should be conducted where there is an a priori

reason to believe that death or disabling injury will occur; except, perhaps, in those experiments where the experimental physicians also serve as subjects.

Code of Ethics: Nuremberg Code

The degree of risk to be taken should never exceed that determined the importance of the problem to be solved by the experiment.

Proper preparations should be made and adequate

facilities provided to protect the experimental subject against possible injury, disability, or death.

The experiment should be conducted only by

scientifically qualified persons. During the course of the experiment the scientist

must terminate the experiment at any stage, if the continuation of the experiment is likely to result in injury, disability, or death to the experimental subject.

Belmont Report Respect for persons:

Individuals should be treated as autonomous agents,

Persons with diminished autonomy are entitled to protection.

Example of lack of respect for autonomy

Deny the status of autonomy Deny the freedom to act on considered

judgments Withhold information necessary to make

judgment

Belmont Report Beneficence:

Do not harm Maximize possible benefits and

minimize possible harms. Justice:

Fairness of distribution of costs and benefits to potential research participants. For example, during the 19th & 20th

centuries the burdens of serving as research subjects fell largely upon poor ward patients, while the benefits of improved medical care flowed primarily to private patients.

Application of Belmont Report Informed Consent

Respect for persons requires that subjects be given the opportunity to choose what shall or shall not happen to them.

Elements of Informed Consent Information: Right to full disclosure

the research procedure, purposes, risks and anticipated benefits, alternative

procedures offering the subject the opportunity to ask

questions and to withdraw at any time from the research.

Issues related to informed consent Covert data collection or concealment Deception

Application of Belmont Report

Comprehension The manner and context in which

information is conveyed is as important as the information itself.

For example, presenting information in a disorganized and rapid fashion, allowing too little time for consideration or curtailing opportunities for questioning, all may adversely affect a subject's ability to make an informed choice.

Application of Belmont Report

Voluntariness . An agreement to participate in research constitutes a

valid consent only if voluntarily given. This element of informed consent requires conditions free of coercion and undue influence.

Coercion occurs when an overt threat of harm is intentionally presented by one person to another in order to obtain compliance.

Undue influence, by contrast, occurs through an offer of an excessive, unwarranted, inappropriate or improper reward or other overture in order to obtain compliance.

Application of Belmont Report Confidentiality

Use study codes on data documents Encrypt identifiable data; Remove face sheets containing identifiers Properly dispose, destroy, or delete study

data / documents; Limit access to identifiable information; Securely store data documents within

locked locations; and/or Assign security codes to computerized

records.

Application of Belmont Report Anonymity

the project cannot link individual responses with participants’ identities

Privacy: Control over the extent, timing and

circumstances of sharing oneself (physically, behaviorally, or intellectually) with others.

Curtains are closed during physical examination. Health history or exam

results are discussed in a private area. This may include asking an accompanying family

member or friend to leave the room temporarily

Application of Belmont Report Assessment of Risks and Benefits “Risk" refers to a possibility that harm may

occur “Benefit" refer to something of positive value

related to health or welfare. For researcher

Proper design Alternative methods of obtaining the information

For reviewer Determining whether the risks that will be

presented to subjects are justified For participants

Assist the determination whether or not to participate

Kinds of Risk

Just plain inconvenience & hassle Emotional or psychological risk Social risk Physical risk Economic risk Legal risk

Risk to Whom? The subject The subject’s institution The family The community The researcher & the institution Science Society

Kinds of Benefit to Subjects

Relationships Knowledge/education/experience Material resources Training opportunity Opportunity to earn esteem of others Empowerment Effective treatment

Who Else Might Benefit? The subject’s institution The subject’s family The community The researcher & the institution The funder Science Society

Vulnerable Groups

Children Mentally or Emotionally Disabled People Physically Disabled People Institutionalized People Pregnant Women

Institutional Review Committee (IRC) in the Jordanian Clinical Research Law

Obligation of the IRC Assure the authenticity of scientific justification Review and approve the entire study protocol Assure the expertise of the research team Assure voluntary and inform consent of participants Report to Jordanian FDA for any adverse event during

the study

Institutional Review of Board and External Review

بسم اہلل الرحمن الرحيم

جامعـــــة آل البيــــت

Al al – Bayt University

Deanship of Academic Research ــميـــالعلــ ــثــالبحــ ــــادةــعم

Principle Investigator: Dr. Ahmad S. Musa, RN, PhD Protocol No.: 06-2011 Title of the Proposal: Jordanian Registered Nurses’ Perception of Providing Nursing Spiritual

Care and it’s Barriers This letter is to officially notify you that the Committee of Ethics of Scientific Research at AL al-Bayt University has met on 19-09-2011 to discuss your submitted research plan entitled “Jordanian Registered Nurses’ Perception of Providing Nursing Spiritual Care and it’s Barriers”. After reviewing your research protocol the committee decided that you have provided adequate protections for the rights of the participants in the study. The committee decided that your protocol adhered to rules and regulations of protecting human rights under research conditions. Based on this decision you are approved to implement your study protocol as of the date of this letter. Principle Investigator is responsible for providing adequate information to the committee if any changes in the research protocol to be occurred either before or after undertaking the research. If you have any questions or if your plans for human subject involvement change substantially from those approved by the committee, please contact the committee director at (962-2-6297052, Ext. 2520) or via email: htashtoush2000@yahoo.com Thank you for submission of your protocol and best wishes for a successful project.

Chair of Committee of Ethics of Scientific Research/Dean of Scientific Research Prof. Dr. Yaseen Al-Soud

Analysis the Ethics of Research Studies

Any physical harm Benefits/Risk Ratio

IRB Approval

Privacy & Confidentiality Policy

References

The Plutonium Files: America's secret medical experiments in the Cold War, by Eileen Welsome, Dial Press, c1999, New York, N.Y., ISBN 0-385-31402-7

Ramahi, I., & Silverman, H. (2009). Clinical Research in Law in Jordan: An Ethical Analysis. Developing World Biothics, 9(1), 26-33.

Questions and Answers